Tags : Trelegy Ellipta

Regulatory

GSK and Innoviva’s Trelegy Ellipta (FF/UMEC/VI) Receive the US FDA’s

Shots: The approval is based on an sNDA which includes data from CAPTAIN study assessing Trelegy (qd, 100/62.5/25, 200/62.5/25, 100/31.25/25, and 200/31.25/25 mcg) vs FF/VI (100/25 and 200/25 mcg) to patients whose asthma was inadequately controlled despite treatment with ICS/LABA Results: Trelegy (qd, easy-to-use inhaler) demonstrated improvements in lung function, presented at ERS Congress. The […]Read More

Pharma

GSK Reports Results of Trelegy Ellipta in P-III CAPTAIN Study

Shots: The P-III CAPTAIN study involves assessing of Trelegy Ellipta (FF/UMEC/VI) (100/31.25/25, 100/62.5/25, 200/31.25/25 and 200/62.5/25 mcg) vs Relvar/Breo Ellipta (FF/VI) (100/25 and 200/25 mcg) in 2,436 patients with uncontrolled asthma prior treated with ICS/LABA across 15 countries The P-III CAPTAIN study results: met its 1EPs; @24wks. 100/62.5/25mcg vs 200/62.5/25mcg, improvement in lung function & […]Read More

Biotech

GSK’s Trelegy Ellipta (Fluticasone Furoate/Umeclidinium/Vilanterol ‘FF/UMEC/VI’) Receives Expanded Level Approval

Shots: The IMPACT study involves assessing of Trelegy Ellipta (qd,100/62.5/25mcg) vs (ICS/LABA Relvar/Breo Ellipta (FF/VI)) (100/25mcg) & ((LAMA)/LABA Anoro Ellipta (UMEC/VI)) (62.5/25mcg) in patients with COPD The Expanded label approval will serve as a maintenance treatment for patients with moderate-to-severe COPD and shown effective results in comparison to ICS, LABA & LAMA. In 2017, Trelegy […]Read More